N/A
Completed N=175
XprESS Registry Study
Source: ClinicalTrials.gov NCT01115309 ↗Enrolled (actual)
175
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Safety Assessments — 2 Participants
Summary
This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Assessments |
2 | — |
| SECONDARY Sino-Nasal Outcome Test (SNOT-20) at 1 Month |
2.1; 1.0 | <0.0001 sig |
| SECONDARY SNOT-20 at 6 Months |
2.0; 0.8 | <0.0001 sig |
| SECONDARY SNOT-20 at 12 Months |
1.9; 0.8 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use
- Willing and able to provide consent
Exclusion Criteria
- Known Samter's Triad
- History of primary ciliary dysfunction
- History of cystic fibrosis
- Known to be immunosuppressed
- Hemophilia
- Currently enrolled in another pre-approval investigational study
Data sourced from ClinicalTrials.gov (NCT01115309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.